On (b)(6) 2018, nakanishi received an e-mail from a distributor (nsk america) about a handpiece overheating.According to nsk america (nam), the information was provided through the adverse event questionnaire about the sgs/sga handpieces as a part of recall activities for those devices.The details are as follows.The event occurred in (b)(6) 2015.(the exact date is unknown.) a dentist was performing a dental procedure using the sga-e2s handpiece (serial no.Unknown).During the procedure, the handpiece overheated and burned a patient's lip.
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Nsk america (nam) took the following actions, but further information about the event and patient was not provided by the dentist.- on december 14, 2018, nam made a phone call to the dental office and left a message.- on january 29, 2019, nam made another phone call to the dentist and left a message.- on may 28, 2019, nam sent an e-mail to the dentist.
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